Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous ECMO With a Heparin Bonded Circuit.
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/2016 |
| Start Date: | December 2016 |
| End Date: | February 2021 |
| Contact: | Robert Raschke, MD |
| Email: | robert.raschke@bannerhealth.com |
| Phone: | 602-839-2792 |
Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous Extracorporeal Membrane Oxygenation (ECMO) With a Heparin Bonded Circuit.
Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support
called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New
materials used in ECMO machines may help prevent clots - this could allow the use of lower
doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to
high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent
clotting, but may cause less bleeding and be safer for patients.
called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New
materials used in ECMO machines may help prevent clots - this could allow the use of lower
doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to
high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent
clotting, but may cause less bleeding and be safer for patients.
Intravenous heparin is considered standard therapy to prevent clotting complications in
patients on ECMO, however the optimal method of heparin dosing has not yet been determined.
International surveys have shown that most ECMO centers use adjusted dose heparin to achieve
an activated clotting time of at least 180 seconds. However, heparin may contribute to the
most common complication of ECMO - bleeding. Advances in material technology have
potentially reduced the thrombogenicity of modern ECMO circuits. Our observational data
suggest that fixed low dose heparin infusion may reduce the rate of bleeding complications
from 75% to 50% compared to standard adjusted-dose heparin, without increasing clotting
complications. We intend to perform a randomized controlled trial in adults receiving
venovenous ECMO comparing these two heparin regimens. The main outcome measures are bleeding
complications and oxygenator failure due to clotting. A safety committee will monitor the
results of the study. Power calculations indicate a sample size of 110 patients is required,
which we estimate will take us five years to achieve.
patients on ECMO, however the optimal method of heparin dosing has not yet been determined.
International surveys have shown that most ECMO centers use adjusted dose heparin to achieve
an activated clotting time of at least 180 seconds. However, heparin may contribute to the
most common complication of ECMO - bleeding. Advances in material technology have
potentially reduced the thrombogenicity of modern ECMO circuits. Our observational data
suggest that fixed low dose heparin infusion may reduce the rate of bleeding complications
from 75% to 50% compared to standard adjusted-dose heparin, without increasing clotting
complications. We intend to perform a randomized controlled trial in adults receiving
venovenous ECMO comparing these two heparin regimens. The main outcome measures are bleeding
complications and oxygenator failure due to clotting. A safety committee will monitor the
results of the study. Power calculations indicate a sample size of 110 patients is required,
which we estimate will take us five years to achieve.
Inclusion Criteria:
- on ECMO for acute respiratory failure, achieving ECMO blood flow rate >3L/min,
- patient or surrogate able to speak/understand English or Spanish
Exclusion Criteria:
- History of heparin-induced thrombocytopenia, decision by clinicians to run ECMO off
heparin due to high bleeding risk,
- pregnancy
We found this trial at
1
site
Click here to add this to my saved trials
